NCT06498284已完成1 期
HM-002-1005 - A Phase 1, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Subjects With Type 2 Diabetes Mellitus
Hua Medicine Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purposes of this study are to:
- Evaluate the safety and tolerability of the study drug.
- Measure how much of the study drug (HM-002-1005) and its breakdown product get into the bloodstream, and how long it takes the body to get rid of them.
- Measure the amount of glucose (blood sugar) and a substance called C-peptide in the bloodstream after receiving the study drug.
Researchers will compare the study drug to a placebo (a look-alike substance that contains no drug).
Participants will:
- Stay 5 days and 4 nights or 6 days and 5 nights at the research site, and have a follow-up phone call 7 days after leaving the research site.
- Take one (1) dose of the study drug or placebo
- Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide
- Have safety tests such as vital sign, ECGs, and glucose measurements
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
matching placebo control
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, of any race, between 18 and 65 years of age, inclusive.
- •Body mass index between 18.5 and 38.0 kg/m2, inclusive.
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- •Type 2 diabetes mellitus, as determined by the American Diabetes Association (ADA) Standard Care Diagnostic Criteria 2023, and
- •are drug naïve, treated with diet and exercise, or
- •have been on a stable dose of ≤2000 mg metformin for ≥1 month, or
- •have been on a stable dose of antidiabetic medications (other than metformin) for ≥90 days.
- •Except for findings consistent with T2DM, in good health, determined from medical history, 12 lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and physical examinations at screening and/or check in, as assessed by the investigator (or designee).
- •Glycated hemoglobin between 6.5% and 9.5%, inclusive.
- •Fasting plasma glucose between 126 and 196 mg/dL (7 and 11 mmol/L, respectively), inclusive. Testing may be repeated once, at the discretion of the investigator (or designee).
- •Other Inclusions
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
排除标准
- •Type 1 diabetes mellitus, maturity onset diabetes of the young, or diabetes mellitus caused by damage to the pancreas or any other condition (eg, acromegaly or Cushing's syndrome).
- •Diabetic neuropathy, retinopathy, or nephropathy.
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- •History of severe hypoglycemia, defined as severe cognitive impairment requiring external assistance for recovery within 3 months prior to dosing; or recurrent hypoglycemia (Level 2), defined as ≥2 episodes within 3 months prior to dosing; or ADA Level 3 hypoglycemia within 6 months prior to dosing.
- •Hypoglycemia unawareness or asymptomatic hypoglycemia.
- •Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening.
- •Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted.
- •Clinically significant history of cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart disease within 1 year prior to screening. Managed hypertension is permitted.
- •Clinically significant history of any central nervous system disease, including transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances within 1 year prior to screening.
- •Clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have had gastric bypass surgery.
- •Clinically significant or unstable history of any hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- •Known or active malignancy, except basal cell carcinoma and cutaneous squamous cell carcinoma.
- •Any hospital admission or major surgery within 90 days prior to screening.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- •Fasting C peptide <0.81 ng/mL.
- •Alanine aminotransferase, aspartate aminotransferase, or gamma glutamyl transferase >2 × the upper limit of normal (ULN); or total bilirubin >1.5× ULN.
- •Uncontrolled hypertriglyceridemia >500 mg/dL.
- •Estimated glomerular filtration rate ≤45 mL/min/1.73 m2, as calculated using the 2021 Chronic Kidney Disease Epidemiology equation.
- •QT interval corrected for heart rate using Fridericia's method >450 msec.
- •Positive hepatitis panel and/or positive human immunodeficiency virus test .
- •Positive pregnancy test.
- •Use of insulin, sulfonylureas, and glinides (eg, repaglinide and nateglinide).
- •Use of any strong or moderate cytochrome P450 (CYP) 3A4 inducers within 28 days prior to dosing or any strong or moderate CYP3A4 inhibitors within 7 days or 5 half lives, whichever is longer, prior to dosing.
- •Use of any P glycoprotein inducers within 14 days prior to dosing or any P glycoprotein inhibitors within 5 days or 5 half lives, whichever is longer, prior to dosing
- •Use of any carboxylesterase 2 inhibitors within 5 days or 5 half lives, whichever is longer, prior to dosing Note: The use of hypertensive therapies is permitted, providing that they are do not meet exclusion criteria 22 to
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days.
- •Positive alcohol test result, or positive urine drug screen (confirmed by repeat), or positive cotinine test at screening or check in.
- •Current drug abuse, defined as the use of any illegal substance or misuse or excessive used of over the counter or prescription drugs; or current alcohol abuse, defined as the inability to stop or control alcohol use, despite adverse social or health consequences.
- •Consumption of alcohol, or caffeine containing foods or beverages within 48 hours, or foods and beverages containing grapefruit or Seville oranges within 7 days prior to check in.
- •Use of tobacco or nicotine containing products within 6 months prior to check in.
- •Receipt or donation of >1 unit (approximately 450 mL) of blood products within 3 months prior to screening.
- •Poor peripheral venous access.
- •Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
研究组 & 干预措施
HM-002-1005 61.5 mg or matching placebo
Experimental
Single dose of 61.5 mg HM-002-1005 or matching placebo
干预措施: HM-002-1005 (Drug)
HM-002-1005 123 mg or matching placebo
Experimental
Single dose of 123 mg HM-002-1005 or matching placebo
干预措施: HM-002-1005 (Drug)
HM-002-1005 184.5 or 246 mg, or matching placebo
Experimental
Single dose of 184.5 or 246 mg HM-002-1005 or matching placebo
干预措施: HM-002-1005 (Drug)
HM-002-1005 369 mg or matching placebo
Experimental
Single dose of 369 mg HM-002-1005 or matching placebo
干预措施: HM-002-1005 (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 11 Days
incidence and severity of adverse events from Day1 to Day 11
Area under the plasma concentration versus time curve (AUC)
时间窗: 72 hour
area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma
maximum observed concentration (Cmax)
时间窗: 72 hours
Cmax of HM-002-1005 in plasma
apparent terminal elimination half life (t1/2)
时间窗: 72 hours
t1/2 of HM-002-1005 in plasma
time of the maximum observed concentration (Tmax)
时间窗: 72 hours
Tmax of HM-002-1005 in plasma
次要结局
- glucose concentration following single oral dose of HM-002-1005(24 hours)
研究者
研究点 (1)
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